Contraception

Ortho Evra (The Patch)

Oral contraceptive pills or birth control pills have been used in this country for over 40 years. Safe and effective, they are one of the most extensively studied medications in the United States. Ortho Evra patch represents a new delivery system of the hormones estrogen and progesterone, which are also found in most oral contraceptives. Ortho Evra was approved by the FDA in 2002 after extensive testing. More than 70,000 birth control patches were clinically tested worldwide in more than 30,000 people.

How does the patch work?

The patch contains two hormones: estrogen and progesterone. These hormones are synthetic versions of naturally occurring hormones. They work primarily by preventing ovulation. Each month's supply contains 3 weekly hormonal birth control patches. The patch is worn for 1 week and replaced on the same day of the week for 3 consecutive weeks, with the 4th week "patch-free." Your period should begin during the "patch-free" week.

How effective is the contraceptive patch?

The patch is 98% to 99% effective when used as directed. Mistakes decrease effectiveness. Studies show that the patch may be less effective for those with body weights of 198 pounds or more. Your medical provider will discuss this with you if it is a concern.

What are the benefits of using the patch?

Regular cycles
The patch can help regulate the menstrual cycle, and this is especially helpful for people with periods that come too often or too infrequently.

Reduced menstrual cramps
The patch can offer significant relief to people with painful menstrual cramps. It also reduces the amount of blood flow during the period. Less blood loss is helpful in preventing anemia.

Acne
We have known for years that oral contraceptive pills can improve some people's acne. The patch may or may not have a beneficial effect on acne.

Other important benefits
The risk of developing benign breast cysts, ovarian cysts, pelvic inflammatory disease, and tubal pregnancy are reduced by taking oral contraceptive pills. The pill is also associated with a markedly decreased risk of uterine cancer and ovarian cancer. Since the patch contains the same hormones as the pill, it is likely to have these same benefits.

What are the side effects of the patch?

Like all medicines, the patch has side effects that you need to be aware of. For the patch, there are rare but serious side effects and minor side effects.

Rare but serious side effects:

Blood clots
The hormones in the patch can make users more prone to form blood clots. Ortho McNeil, the maker of Ortho Evra Patch , has updated the patient information for this product. Patient information now includes a new warning and provides additional information on the differences between the Patch and the Pill. The new information states that hormones from patches applied to the skin get into the blood stream and are removed from the body differently than hormones from birth control pills taken by mouth. You will be exposed to about 60% more estrogen if you use Ortho Evra than if you use a typical birth control pill containing 35 mcg of estrogen. In general, increased estrogen exposure may increase the risk of side effects.

The risk of blood clots in the legs and/or the lungs may be increased with the Patch compared with that of oral contraceptive pills. This risk has been examined in two separate studies. Both studies were conducted using information from insurance claims. One of the studies, which also reviewed patient charts, found a doubling of the risk for blood clots in users of Ortho Evra compared with users of oral contraceptives, and the second study found no increase in risk of blood clots for those using Ortho Evra.

A blood clot can occur in a vein or artery and can have different symptoms depending on where it forms. Clots can occur in the legs, abdomen, heart, lungs, eye, or brain. In the brain, a clot could manifest as a stroke. The risk of these events occuring is very low, but increases in users over 35, in smokers, and in those with high blood pressure, heart disease, diabetes, clotting tendency, or a family history of clotting abnormalities. The warning signs of a blood clot spell out the word ACHES:

Abdominal pain

Chest pain (also shortness of breath)

Headaches (especially those that are new, severe, or associated with persistent dizziness, difficulty speaking, fainting, numbness or weakness in extremities)

Eye problems (blurred vision or loss of vision)

Severe leg pain (and/or redness and swelling in the calf or thigh)

If you develop any of the ACHES side effects OR jaundice (a yellowing of the eyes or skin) while on the patch, call Health Services right away at 401.863-1330. If you need emergency medical attention, call EMS at 401.863-4111. If you are out of town, contact a local medical provider or go to a hospital emergency room.

High blood pressure
The hormones in the patch can raise your blood pressure. This is why we check your blood pressure a few months after you begin using the patch.

Liver tumors
The hormones in the patch have been associated with an increased risk of forming benign liver tumors. This is a very rare occurrence, but you should contact your medical provider if you develop upper abdominal pain while using the patch.

Breast cancer risk
Many patients ask about how hormones in the patch can affect their future risk of developing breast cancer. The jury is still out on this issue. To date, there have been studies which suggest that there is a slightly increased risk of breast cancer in those who have used oral contraceptive pills, which have the same hormones as the patch. However, breast cancer was diagnosed earlier and had a better prognosis than in patients who have never used the pill. We encourage you, especially if you have a strong family history, to explore this risk with your medical provider.

Cervical cancer risk
The risk of developing this type of cancer is slightly increased in people who use hormonal contraceptives. Fortunately, routine Pap smear testing is an excellent screening tool and is recommended on a yearly basis for women using the patch.

More common minor side effects:

Nausea
Some users experience some mild nausea when first starting the patch. Usually this goes away within a short time. If you have persistent problems or unusually severe nausea, contact your medical provider.

Spotting or breakthrough bleeding
This is vaginal bleeding that occurs during weeks wearing a patch. This is a very common side effect during the first 3 months of patch use. Please see the section on Frequently Asked Questions for a discussion of this side effect.

Breast tenderness
Mild breast tenderness may occur after starting the patch. The tenderness can be reduced by decreasing your caffeine and salt intake and by wearing a bra with good support. Usually it gets better within a few weeks. If you notice persistent discomfort or a discrete lump, make an appointment with your medical provider.

Mood changes
Some users may notice changes in their emotional status: depressed mood or emotional instability. If you have a history of depression, it is important to monitor your progress carefully when starting the patch. If you notice changes in your mood after beginning the patch, call your medical provider.

Decreased sex drive
While sex drive is affected by many things, the hormones in the patch can be a factor in decreased sex drive. If you are noticing this side effect, let your medical provider know.

Weight gain
Many patients ask about this side effect. Studies have shown that weight changes in young people taking hormonal contraceptives are no different than for those who don't take hormones. Some users have noticed mild weight change (1 to 2 pounds) and mild fluid retention when using the patch. Using the patch should not make you gain 10 or 15 pounds.

Gallbladder disease
The patch may accelerate the formation of gallbladder stones in users who have a strong family history of gallstone disease.

Cervical changes
Use of the patch, as well as pregnancy, may be associated with some cellular changes on the cervix, called a cervical ectropion. The delicate mucus secreting cells that line the inside of the cervix become present at the outer opening of the cervix. This can make the cervix more vulnerable to sexually transmitted diseases.

Vaginal discharge
Everyone who menstruates has a cyclical vaginal discharge. Some patch users may notice subtle changes in this discharge, but most won't notice any changes.

Application site
Local reactions may occur.

How can I get the patch at Health Services?

Before you receive a prescription for the patch, you will need to be seen for a visit to take your medical history and perform a brief physical exam. Call Health Services at 401.863-3953 to schedule an appointment. The only charges during your visit will be for lab testing, if necessary.

After you choose the patch, you will probably receive a prescription for a 3 month supply (1 month of patches with 2 refills). You will be seen towards the end of the 3rd month for a brief appointment to see how you are doing and to check your blood pressure. If the method is working well for you, you will be given a prescription to last 6 to 9 months.

Our Health Services pharmacy carries the Ortho Evra patch. The patch costs $135.95 per month or $112.95 for Xulane, the generic version, and your insurance plan may cover some or all of this cost. If you have Brown's student health insurance, there is no co-pay for contraceptives, including Ortho Evra. If you run out of patches or one falls off, please call Health Services, and we can help out until your next appointment.

How do I use the patch?

The patch uses a 28-day or 4-week cycle. You should apply a new patch on the same day of the week for 3 consecutive weeks, for a total of 21 days. You should not apply a patch during the 4th week. Your menstrual period should start during this "patch-free" week. Every new patch should be applied on the same day of each week. This day will be your "patch change day." For example, if you apply your first patch on a Monday, all of your patches should be applied on a Monday. You should wear only one birth control patch at a time.

On the day after week 4 ends, you should begin a new 4-week cycle by applying a new patch.

Sunday Start

Apply your first patch on the first Sunday after your menstrual period starts (day 1). If your menstrual starts on a Sunday, you should start the patch that same day. You must use back-up contraception, such as a condom and spermicide for the 1st week of your 1st cycle. (Sunday will be the "patch change day.")

The patch may be worn on the buttocks, abdomen, upper torso (front and back, excluding the breasts) or upper outer arm.

Wear the patch continuously for 7 days (one week). On day 8 (the "patch change day," eg, this would be Sunday for a Sunday start patient), remove the used patch, discard it and apply a new one immediately to one of the four areas described above.

Apply a new patch for week 2 (on day 8) and week 3 (on day 15), on your "patch change day." To avoid irritation, do not apply the new patch to the same exact place on your skin.

Do not wear a patch on week 4. Your period should start during this week.

Begin your next 4-week cycle by applying a new patch on your normal "patch change day," the day after Day 28--no matter when your period begins or ends.

First Day Start

Apply your first patch during the 1st 24 hours of your period (day 1). This is considered the "patch change day." If the patch is not applied within the 1st 24 hour of your period, you must use back-up contraception, such as a condom and spermicide for 1 week after starting the patch.

The patch may be worn on the buttocks, abdomen, upper torso (front and back, excluding the breasts) or upper outer arm.

Wear the patch continuously for 7 days (one week). On day 8 (the "patch change day"), remove the patch, discard it and apply a new one immediately to any of the 4 areas described above.

Apply a new patch for week 2 (on day 8) and for week 3 (on day 15), on your "patch change day." To avoid irritation, do not apply the new patch to the same exact place on your skin.

Do not wear a patch on week 4. Your period should start during this week.

Begin your next 4-week cycle by applying a new patch on your normal "patch change day," the day after Day 28--no matter when your period begins or ends.

We recommend using condoms consistently with the patch to protect against sexually transmitted infections (STIs). The patch offers no protection against STIs.

Where can I wear the patch?

You can wear the patch on 1 of 4 areas of the body: your buttocks, abdomen, upper torso (front and back, excluding the breasts) or upper outer arm.

You should not place the patch on skin that is red, irritated or cut. To ensure the effectiveness of the patch, you should not place the patch on areas of your skin where make-up, lotions, creams, powders or other products are or will be applied.

The patch should not be worn on any other areas of the body.

How do I apply the patch?

Open the foil pouch by tearing it along the top edge and one side edge. Peel the foil pouch apart and open it flat. You will see that the patch is covered by a layer of clear plastic. It is important to remove the patch and the plastic together from the foil pouch. Using your fingernail, lift one corner of the patch and peel the patch and the plastic off the foil liner. Sometimes patches can stick to the inside of the pouch--be careful not to accidentally remove the clear liner as you remove the patch. Peel away half of the clear plastic and be careful not to touch the exposed sticky surface of the patch with your fingers. Apply the sticky side of the patch to the skin you've cleaned and dried, then remove the other half of the clear plastic. Press firmly on the patch with the palm of your hand for 10 seconds, making sure the edges stick well. Run your fingers around the edge of the patch to make sure it is sticking properly. Check your patch daily to make sure all edges are sticking.

How does the patch stay on?

The patch uses clinically proven technology, which has a layer containing both the medication and an adhesive that keeps the patch on the skin for an entire week. When applying the patch, it is important to press down firmly on the patch with the palm of your hand for 10 seconds, making sure that the edges stick well. The patch remains attached and effective even when you bathe, swim, exercise, or wear it in humid conditions. In clinical trials, less than 2% of contraceptive patches had to be replaced because of complete detachment and less than 3% had to be replaced because of partial detachment. In the rare event that you need an extra patch, you can call Health Services for a replacement patch.

On the "patch change day," can I place it on a different area of the body?

Yes. The new patch can be placed on one of the four recommended areas: the buttocks, abdomen, upper torso (front and back, excluding the breasts) or upper outer arm.

Can I change the location of the patch in the middle of the week?

It is not recommended that you move your patch to a new location in the middle of the week. Attempting to change the location of a patch may cause it to become loose.

How do I change my "patch change day?"

If you wish to move your "patch change day" to a different day of the week, finish your current cycle, removing your 3rd patch on the correct day. During week 4, the "patch-free" week, (day 22 through day 28), you may choose a new "patch change day" by applying a new patch on the day you prefer. You now have a new day 1 and a new "patch change day." You should never have the patch off for more than 7 days in a row.

What if I forget to change the patch?

At the start of any patch cycle (Week 1—day 1): If you forget to apply your patch, you may become pregnant--you must use back-up contraceptives such as a condom and spermicide for one week. Apply the 1st patch of your new cycle as soon as you remember. You now have a new "Patch Change Day" and day 1. You must use back-up contraception for the 1st week of your new cycle. You should never have the patch off for more than 7 days.

In the middle of your patch cycle (Week 2 or week 3): If you forget to change your patch for 1 or 2 days, remove the patch as soon as you remember and apply a new patch. Apply your next patch on your normal "patch change day." No back-up contraception is needed. During week 2 or week 3, if you forget to change your patch for more than two days, you could become pregnant. Start a new 4-week cycle as soon as you remember by removing the old patch and applying a new patch. You now have a different "patch change day" and new day 1. You must use back-up contraception, such as a condom and spermicide for the 1st week of your new cycle. You should never have a patch off for more than 7 days.

At the end of your patch cycle (Week 4): If you forget to remove your patch, take it off as soon you remember. Start your next cycle on your normal "patch change day," the day after day 28. No back-up contraception is needed.

At the start of your next patch cycle, day 1 of week 1: If you forget to apply your patch, you could become pregnant. Apply the first patch of your new cycle as soon as you remember. You now have a new "patch change day" and a new day 1. You must use back-up contraception for the first week of your new cycle. You should never have a patch off for more than 7 days.

What should I do if a patch seems loose, partially lifts up off my skin or falls off?

For less than 24 hours: You should try to reapply it or apply a new birth control patch immediately. No back-up contraception is needed and your "patch change day" will remain the same. You can reapply the patch by following these instructions:

Do not try to reapply a patch if it's no longer sticky, if it has been stuck to itself or another surface, if it has other material stuck to it or if it has become loose or has fallen off before.

Press down firmly on the patch with the palm of your hand for 10 seconds, making sure that the edges stick well.

Then run your fingers around the edge of the patch.

Do not use tapes or wraps to keep the patch in place.

If the patch does not stick well, remove it and then apply a replacement birth control patch. This patch should be replaced on the original "patch change day." Single replacement patches are available at the pharmacy.

For more than 24 hours, or if you are not sure how long: You may become pregnant. Start a new 4 week cycle immediately by applying a new patch. You now have a new day 1 and a new "patch change day." You must use back-up birth control, such as a condom and spermicide for the first week of your new cycle.

What should I do if a patch seems loose, partially lifts up off my skin or falls off?

For less than 24 hours: You should try to reapply it or apply a new birth control patch immediately. No back-up contraception is needed and your "patch change day" will remain the same. You can reapply the patch by following these instructions:

Do not try to reapply a patch if it's no longer sticky, if it has been stuck to itself or another surface, if it has other material stuck to it or if it has become loose or has fallen off before.

Press down firmly on the patch with the palm of your hand for 10 seconds, making sure that the edges stick well.

Then run your fingers around the edge of the patch.

Do not use tapes or wraps to keep the patch in place.

If the patch does not stick well, remove it and then apply a replacement birth control patch. This patch should be replaced on the original "patch change day." Single replacement patches are available at the pharmacy.

For more than 24 hours, or if you are not sure how long: You may become pregnant. Start a new 4 week cycle immediately by applying a new patch. You now have a new day 1 and a new "patch change day." You must use back-up birth control, such as a condom and spermicide for the first week of your new cycle.

Can I wear the patch in the shower or while swimming or exercising?

Yes. The patch should be worn continuously for 7 days. The patch adheres well to the skin, allowing you to perform your daily activities such as bathing, showering, swimming, and exercising without interruption.

Can I decorate or cut my patch?

No. To ensure the effectiveness of the patch, you should not write on the patch or alter the patch in any way. Modifying the patch may affect the amount of medication that is delivered through the skin and into the bloodstream, which may increase the risk of becoming pregnant.

Would lotions affect the patch?

Always apply your patch to clean, dry skin. Do not use creams, oils, powder or make up on your skin where you will put a patch or near a patch you are wearing. These may cause the patch to become loose.

How do I clean dirt or a dark ring around the patch?

It is not recommended that you clean the edges of the patch prior to removal on the "patch change day." Lifting the edges of the patch may cause it to become loose or fall off. Using creams, oils, or powders near the patch may cause it to become loose. On your "patch change day," when you remove the patch, if a small ring of adhesive is left on your skin, you can remove it by rubbing a small amount of baby oil on the area.

How do I remove and discard the patch?

When removing your used patch, simply lift one corner and quickly peel back. If a small ring of adhesive is left on your skin, remove it by rubbing a small amount of baby oil on the area. The used patch still contains some medicine--throw it away after carefully folding it in half so that it sticks to itself.

Are there special instructions for storage?

Patches should be stored in their protective pouches. Apply immediately to skin upon removal from the protective pouch. Store at room temperature (77 degrees), with short variations in temperature permitted (59 to 86 degrees). Do not store in the refrigerator or freezer.

Can a person with sensitive skin use it?

The patch may cause skin irritation. It is advisable to avoid placing the patch on skin that is red, irritated or cut. If you have sensitive skin, you may wish to consult with your medical provider prior to use. If mild irritation develops during use, the patch can be removed and a new patch may be applied immediately to a new location until the next "patch change day."

How do I switch from birth control pills to the patch?

Switching to the patch is similar to switching to another birth control pill. If you are switching from birth control pills to the patch, wait until you get your period. If you do not get your period within 5 days of taking the last active pill, check with your medical provider to be sure that you are not pregnant before starting the patch. After starting the patch, you should use back-up contraception, such as a condom and spermicide for 1 week.

Does it matter which patch I use from the box?

No. Each patch delivers the same amount of medication each week. Therefore, the patches can be used in any order. However, a new patch must be applied on the same day of the week for 3 consecutive weeks. The 4th week is "patch free." This patch-free week is similar to the placebo or 4th week with birth control pills during which inactive pills or no pills are taken.

Do I only need to wear the patch when I have sex?

The patch will not be effective if you only wear it when you have sex. The patch uses a 28-day, 4-week cycle. You will apply a new patch on the same day of the week for 3 consecutive weeks, for a total of 21 days. You will not apply a patch during week 4. Do not skip patches even if you do not have sex very often.

How long do I need to wear the patch before I am protected from pregnancy?

For Sunday start, you must use back-up contraception (such as a condom and spermicide) for the 1st week of your 1st cycle. If these instructions are followed, the patch will be as effective during the 1st cycle as it will be in subsequent cycles of use.

For First Day start, if you apply your 1st patch during the 1st 24 hours of your period, no additional back-up contraception is required. If you do not use the 1st patch within the 1st 24 hours of your period, you must use back-up contraception (such as a condom and spermicide) for the 1st week of your 1st cycle. If these instructions are followed, the patch will be as effective during the 1st cycle as it will be in subsequent cycles of use.

What should I do if I take other medications?

Certain drugs may interact with hormonal contraceptives, including the patch, to make them less effective in preventing pregnancy or cause an increase in breakthrough bleeding. Such drugs include rifampin, drugs for epilepsy such as barbituates (for example, phenobarbital), anticonvulsants such as topiramate (Topomax), carbamazepine (Tegretol), phenylbutazone (Butaxolidin), certain drugs used in the treatment of HIV or AIDS and possibly some antibiotics. Pregnancies and breakthrough bleeding have been reported by users of combination birth control pills who also use some form of St. John's Wort.

As with all prescription products, you should notify your medical provider of any other medications you are taking. We encourage users to use back-up contraceptive, such as a condom and spermicide, when you take drugs that can make the patch less effective.

Does the patch affect my ability to get pregnant later on?

There is no evidence that the use of hormonal contraceptives at any time is related to infertility.

What should I do if I don't get my period?

While your period is much lighter on the patch, you will get a period, usually a few days after removing the 3rd patch (during the patch-free week). Sometimes, however, no period occurs due to stress or illness. If you've worn your patch regularly, pregnancy is unlikely. However, we do recommend taking a pregnancy test to rule out this possibility before starting your next patch. We perform confidential urine pregnancy tests at no cost. If you aren't getting a regular period on the patch, talk to your medical provider.

Do I need to stop using the patch from time to time?

There is no evidence that you should "rest" your body from the patch periodically. It's generally not recommended to stop the patch unless you plan to stay off for 3 months. The best time to stop is at the end of your 3rd week. Stopping during a patch week will usually be followed by some bleeding; count this as a menstrual period. Remember that you could become pregnant as soon as you stop using the patch. However, your next normal period may be delayed. If normal menstruation does not return in 8 weeks, see your medical provider to determine why.

Can I skip a period on purpose?

There may be a week when you would really like to avoid your period because of a special trip or event. You may accomplish this by not taking a week off the patch. Instead, start your next patches at the end of week 3. Your period should hold off until you finish this new pack. We encourage you to try this only after using the patch successfully for a few months and have seen how your body adjusts. If you'd like to try this method, call your medical provider to discuss the details.

What if I have breakthrough bleeding?

Spotting or bleeding during weeks 1 to 3 is termed breakthrough bleeding. It is extremely common during the first three months of patch use. This bleeding can usually be ignored and should resolve by the third month. If light bleeding persists for more than 5 to 7 days or heavy bleeding persists for more than 2 to 3 days, call your medical provider.